Regulatory Affairs Manager

SRG

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Job ID :

2017


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Wigan,Wigan,


Key Skills :

Regulatory Affairs, Herbal, OTC, Manager


Salary :

£450000000000 per annum


Date Posted :

10 May, 2016



Company Name :

SRG


Location1 :

Wigan




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

My Client a global natural medicine company committed to identifying and developing leading natural medicines with the best evidence of effectiveness, quality and safety, and marketing them around the world. They have opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Manager. This is a permanent opportunity based in Wigan.

Responsibilities

Timely and accurate submission of variations leading to minimum RFIs and granting of variations to expected time lines
* Avoidance of contradiction between license and internal documentation and practices
* Maintain an up to date knowledge of Regulatory requirements for all products
* Submission and maintenance of Common Technical Dossiers (CTD) documentation to agreed timelines
* Meeting agreed timelines for THR renewals project (2016/2017)
* Ensure the continued development of KPIs and fulfilment of defined limits
* Development of staff
* Working within agreed budgets
* Proactive management of Regulatory and PV activities ensuring legal compliance of our products including licensed medicines (mainly herbal), food supplements and cosmetics
* Continual improvement of Regulatory processes to develop individuals and promote in-house customer requirements, as well as regulatory requirements
* The maintenance of systems ensuring information about all suspected reactions which are reported to the company is collected, evaluated and collated so that it may be accessed at a single point
* Supporting cross-departmental objectives within a regulatory compliant environment
* Manage and maintain Herbal Product Licenses / THRs
* Liaise with the MHRA, medical advisor's, QPs, internal business functions and third party agencies
* Proactive member of the Management Team and Executive Management Team
* Ensuring compliance with local regulatory policy and procedures
* Setting, consulting, implementing and tracking objectives including continual improvement
* Review and approve labelling/ packaging and PIL
* Prepare variation submissions to the MHRA
* Monitor the development of current directives and the MHRA requirements
* Regularly review ASPRs from the MHRA portal and document accordingly
* Assessment of yearly objectives (fulfilment of defined objective requirements)
* Maintain an up to date knowledge of Regulatory requirements for all products

Requirements
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
* Scientific academic education
* Minimum 5 years of experience in pharmaceutical industry within Regulatory Affairs
* Experience in the OTC sector within Regulatory Affairs
* Financial and budgeting skills and experience
* BSC in a science degree
* Interest in Herbal Medicines

Preferred

* In depth knowledge and understanding of ISO 9001, ISO 13485 and GMP
* Experience managing cross-functional projects
* Knowledge of Herbal Medicines
* Agile and resourceful management
* Empower and develop people
* Accountability for delivering results
* Develop and drive the department and the business
* Negotiate with UK Licensing authority and other authorities

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.


Company Name:

SRG


Headquarters:

9 Devonshire Square,


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC2M 4H


Website:

www.srg.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

+44 (0) 203 096 47 0


For more information,visit www.srg.co.uk.

View all SRG Jobs



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